Biostatistics, Epidemiology, and Research Design (BERD) expertise is essential to the successful conduct of clinical and translational (CT) studies. Due to extraordinary recent advancement in computational capabilities and data-driven decision processes, there has been significant growth in the number of statistical techniques and research design methodology for CT studies. The Data Management and Statistical Core (DSMC) will collaborate with the P01 investigators on the proposed projects by leveraging resources to provide study design, data management, and statistical support.
DMSC specific aims i nclude: 1. To provide research design and methodological support in the planning, conduct, and analysis of data from all proposed projects. 2. To establish and monitor systems for data collection, management, processing, quality control, data assurance, security, communication, documentation, and long term storage of data. 3. To provide statistical analysis support for researchers in this study and develop innovative study design solutions for complex study designs, encourage collaboration across studies, facilitate publications, and disseminate findings In achieving these aims, our DMSC will ensure timeliness and consistency across studies with respect to standardization of data collection forms, data entry, data cleaning, conducting data quality checks and setting up procedures for reporting and analyzing data. Our DMSC will be responsible for the overall data management, quality assurance procedures, study design and statistical analysis of the data as well as be the long-term repository of the data. Furthermore, the faculty in the DMSC will have an excellent opportunity to implement methodological improvements for conducting complex clinical and genetic studies. Database design and computer program development will be conducted in accordance with accepted best practices.

Public Health Relevance

Biostatistics, Epidemiology, and Research Design (BERD) expertise is essential to the successful conduct of clinical and translational studies. This DMSC will provide research design and methodological support for the four projects in this application using a a distributed team approach with a central core of biostatistics, bioinformatics, and database expertise with support from personnel in Administrative Core A.